Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114474784 | 11447478 | 4 | F | 2009 | 20160831 | 20150902 | 20160908 | EXP | US-JNJFOC-20150807887 | JANSSEN | 11.48 | YR | C | M | Y | 0.00000 | 20160908 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114474784 | 11447478 | 1 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | DOSE: 0.25-1MG | Y | U | UNKNOWN | 20272 | TABLETS | ||||||
| 114474784 | 11447478 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS | |||||||||
| 114474784 | 11447478 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | Y | 0 | 600 | MG | UNSPECIFIED | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114474784 | 11447478 | 1 | Autism |
| 114474784 | 11447478 | 2 | Product used for unknown indication |
| 114474784 | 11447478 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114474784 | 11447478 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114474784 | 11447478 | Drug ineffective | |
| 114474784 | 11447478 | Emotional distress | |
| 114474784 | 11447478 | Gynaecomastia | |
| 114474784 | 11447478 | Increased appetite | |
| 114474784 | 11447478 | Intentional self-injury | |
| 114474784 | 11447478 | Muscle spasms | |
| 114474784 | 11447478 | Overweight |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 114474784 | 11447478 | 1 | 2005 | 201105 | 0 |